Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

ZFX05001956 — Class I MDR by Zfx GmbH

MD Atlas
Zfx GmbH

EUDAMED last updated this device on May 4, 2026

ZFX05001956

42518817-AM-I-Scanbody-YW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Zfx GmbH
UDI-DI code: 04251881761221
Reference / catalog number: ZFX05001956

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Zfx GmbH
SRN: DE-MF-000018101
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251881761221
Basic UDI-DI: 42518817-AM-I-Scanbody-YW
Reference / catalog number: ZFX05001956
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: INTRA-3I-OS-MACH-6.0-H4
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 6 MU50
4 MU50

EMDN nomenclature code(s)

Q01010199DENTAL RESTORATION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

ZFX05Z-ZB-CE-3442518817-GT-D-Scanbody-D7On the market ZFX02HLD3642518817-GT-Tool-6DOn the market ZFX02HLD2842518817-GT-Tool-6DOn the market ZFX02HLD2142518817-GT-Tool-6DOn the market ZFX05Z-ZB-TSV-3542518817-GT-D-Scanbody-D7On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.